Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule

Forms and Documents

Document Name	Status
0572 SS 2008doc 2.doc Supporting Statement A	2008-12-17

IC Document Collections

IC ID	Document Title	Status
6295	Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule	Modified
188335	Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule	New
188334	Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule	New
188333	Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule	New

ICR Details

OMB Control No: 0910-0572	ICR Reference No: 200901-0910-004
Status: Historical Active	Previous ICR Reference No: 200509-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/13/2009
	Date Received in OIRA: 01/16/2009
Terms of Clearance: This information collection request is approved as revised. Note that the burden tables were changed to be consistent with what was reported in the supporting statement and to reflect that the burden changes were due to adjustment, consistent with submission as "extension without change." Approval is consistent with the understanding that burden is decreasing due to the fact that submissions of certain types of information are no longer required by regulation (i.e. the final rule required the information to be submitted within 3 years from the effective date of the rule and those 3 years have passed). In the future, FDA should provide more fulsome explanation in the supporting statement when burden or cost is changing and ensure that the burden and cost estimates match up with the estimates provided in the supporting statement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2012	36 Months From Approved	04/30/2009
Responses	973	0	1,911
Time Burden (Hours)	471,295	0	501,383
Cost Burden (Dollars)	0	0	0

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Abstract: The final rule would revise the requirements governing the content and format of labeling for human prescription drug products. The final rule is part of FDA's risk management strategic initiative. The revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling, and is an essential step forward towards the success of the agency's electronic labeling initiative. Respondents include persons, businesses, including small business and manufacturers.

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Authorizing Statute(s): US Code: 21 USC 201.56 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 56592	09/29/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 904	01/09/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	973	1,911	0	0	-938	0
Annual Time Burden (Hours)	471,295	501,383	0	0	-30,088	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The changes in burden from the information collection in the final rule are the result of reductions in the number of submissions that have occurred because 3 years have expired under the implementation plan.

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Annual Cost to Federal Government: $1,946,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/16/2009

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